Détails concernant le projet

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CSC - Cost-sharing contracts

Objectif

During the last 30 - 40 years the use of disposables and medical devices made of plastics has gained an increasing application in the modern health care system. The Medical Device Market within EU amounts to 9 - 10 billion ECU all inclusive. The size of the European Medical plastic Tubing Market constitutes approx. 1.5 - 2 billion ECU. Plastic tubes for medical applications have to be flexible but, simultaneously, they need to have a certain strength, as well as clarity, lightness and be inexpensive too. The strength and flexibility allow the tubes to be handled easily, so they can be bent around obstacles, e.g. set by the normal human anatomy, as it is seen by e.g. application of a stomach tube via the throat or a suction catheter via the nose and respiratory system or an intravenous catheter in the intravascular system. However, all flexible tubes do not show the same behaviour during bending. Some tubes can bend excessively without kinking which means collapsing and thereby drastically reducing the cross sectional area. Others kink easily. In medical applications, this reduction of the flow area can cause severe reduction in the flow of vital fluids or gases. Despite the fact that kinking of medical tubes is a very critical problem, the kinking phenomenon itself is currently not very well described in the scientific literature, and a generally accepted definition and description of kinking of plastic tubes does not exist. For the same reasons a suitable test method for measurements of kinking properties does not at present exist. Because of the lack of a suitable test method the CEN/TC 205 WG6, dealing with standards for catheters and drainage systems, still has open clauses on this item in two of their standards. The objectives of this project are therefore as follows: * To identify the most adequate kinking parameters * To develop a harmonized test method to determine the kinking properties of Medical Tubes * To verify the practicality of the test method on a broad range of Medical Tubes In order to fulfil the principal objectives, 5 work packages have been set up which include: 1. Information retrieval, theoretical analysis and mathematical modelling of the kinking phenomenon 2. Selection of relevant polymer materials plus sample sizes 3 . Extrusion of samples 4. Experimental set-up of test instruments for intravascular as well as non-vascular catheters 5. Verification of the test methods for kinking measurements Kinking, Medical Tubes, kink-resistance, tube dimensions, catheters, intravascular. KEYWORDS (max 10): catheters